This invention relates to pharmaceutical compositions, especially pharmaceutical compositions suitable for oral administration such as mouth washes and toothpastes, which are useful for treating or preventing anaerobic bacterial infections, especially diseases of the oral cavity, in humans or lower animals. This invention further relates to a method for treating or preventing anaerobic bacterial infections, especially diseases of the oral cavity such as gingivitis and periodontal disease, as well as acne, in humans or lower animals.
Virtually all anaerobic infections arise endogenously. Anerobic bacteria are a part of the normal flora of the skin. They also exist prevalently on all mucosal membrane surfaces as endogenous flora. Given the proper circumstances and opportunity to penetrate tissues, anaerobes from the endogenous flora set up infections, such as gas gangrene, vulvovaginal abscess, chronic sinusitis, and Vincent's disease.
Periodontal diseases are believed to involve anaerobic bacterial infection. Periodontal disease affects the periodontum, which is the investing and supporting tissues surrounding a tooth (i.e., the periodontal ligiment, the gingiva, and the alveolar bone). Gingivitis and periodontitis are inflammatory disorders of the gingiva and the periodontal ligiment, respectively. Gingivosis and periodontosis are more severe conditions involving degenerative disorders of the tissue. Combinations of inflammatory and degenerative conditions are termed periodontitis complex.
Periodontal disease is a major cause of tooth loss in adults. Tooth loss from periodontal disease is a significant problem beginning at about age 35, but even by about age 15, it is estimated that about 4 out of 5 persons already have gingivitis and about 4 out of 10 have periodontitis.
While good oral hygiene, as achieved by brushing the teeth with a cleansing dentifrice, may help reduce the incidence of periodontal disease, it does not necessarily prevent or eliminate its occurrence. This is because microorganisms, especially anaerobes, contribute to both the initiation and progress of periodontal disease. Thus, in order to prevent or treat periodontal disease, these microorganisms must be suppressed by some means other than simple mechanical scrubbing.
It is known that certain anaerobe infections may be treated with some degree of effectiveness with hyperbaric oxygen or hydrogen peroxide. Other forms of treatment with oxygen or oxygen compounds are also known in the art. For example, U.S. Pat. No. 3,988,433, to Benedict, issued Oct. 26, 1976, discloses short-chain alkyl diperoxy acids, and meta- or parasubstituted aromatic peroxy acids as being useful for preventing or removing stains from teeth. These organic peroxy acids are also disclosed as being antibacterial agents for controlling the bacterial population in the mouth.
British Patent No.1,565,672, to Goupil, published Apr. 23, 1980, discloses a toothpaste which generates oxygen. It is useful for prophylaxis and treatment of bucco-dental infections.
U.S. Pat. No. 4,350,681, to Fulton, issued Sept. 21, 1982, discloses benzoyl peroxide which is stabilized by glycerol dispersed in an aqueous medium. A combination of this mixture with a mild abrasive, wetting agent, and thickener, adjusted to pH between 3.5 and 5.0 is suitable for use as a toothpaste. It is disclosed to be an antibacterial for gingival inflammation.
In spite of the large amount of research aimed at developing antibacterial compositions such as acne cleansers, therapeutic dentifrices, and mouth washes, there is a continuing need to identify additional safe and effective antibacterial compositions.
It is therefore an object of the present invention to provide pharmaceutical compositions which are useful for treating or preventing anaerobic bacterial infection in humans or lower animals. In particular, it is a further object of this invention to provide oral pharmaceutical compositions, such as mouth washes and toothpastes, which are useful for treating or preventing diseases of the oral cavity, such as gingivitis and periodontitis, in humans or lower animals; and further which are cosmetically acceptable.
It is a further object of the present invention to provide a method for treating or preventing anaerobic bacterial infections, especially diseases of the oral cavity, in humans or lower animals.